A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program (PCPCWLS)
This study has been completed.
Sponsor:
University of Colorado, Denver
Collaborator:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00907660
First received: May 20, 2009
Last updated: February 1, 2013
Last verified: August 2010
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Purpose
We hypothesize that individuals provided with 1 meal per day of portion-controlled foods (shakes and prepared entrees) will lose as much weight as individuals provided with 2 meals per day of portion-controlled foods. The study is designed to assess whether equal weight loss can be achieved at a lower cost to the health care system (or health care payer), with patients contributing some of the cost of their own treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Obesity |
Behavioral: Weight loss counseling Dietary Supplement: Portion-Controlled Foods |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomized Trial Comparing Two Doses of Portion-Controlled Foods Within a Primary Care Weight Loss Program |
Resource links provided by NLM:
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- Weight change [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Health-related quality of life [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Blood pressure [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Waist circumference [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
- Body mass index [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 50 |
| Study Start Date: | May 2009 |
| Study Completion Date: | March 2010 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Full Dose
Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 2 meals per day of portion-controlled foods (shakes and entrees)
|
Behavioral: Weight loss counseling
Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
Other Names:
Dietary Supplement: Portion-Controlled Foods
Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.
Other Name: Meal replacements
|
|
Experimental: Half dose
Provision of 8 weight loss counseling sessions, calorie guide, pedometer, meal plan, and 1 meal per day of portion-controlled foods (shakes and entrees)
|
Behavioral: Weight loss counseling
Monitoring of weight; review of food and physical activity records; counseling to reduce calorie intake by 500-1000 calories per day
Other Names:
Dietary Supplement: Portion-Controlled Foods
Consumption of shakes, meal bars, and prepared entrees for 2 out of 3 meals per day during the 14 weeks of the study. "Full dose" patients are provided with both meals by the study; "half dose" patients are provided with one out of two meals by the study.
Other Name: Meal replacements
|
Detailed Description:
The study has two goals. First, it will assess the efficacy of a weight loss program, using a combination of counseling by peer weight coaches and portion-controlled foods. Second, the study will test the effect of varying the "dose" of portion-controlled foods provided to patients by randomly assigning individuals to receive half or all of the food required to follow a meal replacement regimen. The primary endpoint of the study will be weight change. Secondary endpoints will include adherence to the recommended eating plan, health-related quality of life, as well as changes in waist circumference and blood pressure. The provision of "half-dose" portion-controlled foods (1 meal per day) is hypothesized to be non-inferior to provision of "full-dose" (2 meals per day). The goal of non-inferiority is important because it can demonstrate that health care payers wishing to support weight loss programs can achieve equivalent results at a lower cost. All patients have the choice regarding their use of portion-controlled foods in the study, and no patients will be asked to leave the study because of non-adherence.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients from the University Medicine Denver, University Medicine Anschutz, and A.F. Williams clinics meeting the following criteria
- Age 18 or older
- Able to keep a food record for 3 days prior to study entry
- Able to give informed consent
- Willing to accept randomization to either treatment condition, to attend all sessions, and to complete study-related assessments
- Body mass index (BMI) ≥ 30 kg/m2 and < 50 kg/m2
- Elevated waist circumference (≥ 88 cm for women, ≥ 102 cm for men) + any one of the following:
- Glucose intolerance (fasting glucose ≥ 100 or non-fasting glucose ≥ 140, including type 2 diabetes); individuals taking medications for diabetes qualify automatically
- Elevated blood pressure (≥130/85), including hypertension (≥140/90); individuals taking anti-hypertensive medication qualify automatically
- Hypertriglyceridemia (TG ≥ 150); individuals taking lipid-lowering medications qualify automatically
- Decreased high-density lipoprotein (HDL) cholesterol (< 40 for men, < 50 for women)
- Obstructive sleep apnea
Exclusion Criteria:
- Medical conditions in which significant weight loss is normally contraindicated (e.g. pregnancy, congestive heart failure requiring diuretics, poorly controlled diabetes, Stage 4 or 5 chronic kidney disease, clinically evident cirrhosis, other severe internal organ disease); exceptions may be made if a referring physician documents that it is safe and appropriate for the individual to lose weight
- Treated for cancer within the past 5 years, except for basal cell or squamous cell skin cancer; exceptions may be made with written permission from a physician
- Weight gain or loss of ≥5% of weight in the past 6 months; patients who have not been weight stable may be re-screened in 3 months
- Concurrent use of corticosteroids or second-generation antipsychotic medications (exceptions may be made for individuals using these medications who have been weight stable for 6 months)
- Psychiatric diagnoses likely to affect adherence to a research study protocol (e.g., poorly controlled schizophrenia, active substance abuse)
- Prior or planned bariatric surgery
- Participation in an organized weight loss program (e.g., Weight Watchers) at the time of enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00907660
Locations
| United States, Colorado | |
| Center for Human Nutrition | |
| Denver, Colorado, United States, 80220 | |
Sponsors and Collaborators
University of Colorado, Denver
Investigators
| Principal Investigator: | Adam G Tsai, MD, MSCE | University of Colorado, Denver |
More Information
No publications provided
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00907660 History of Changes |
| Other Study ID Numbers: | 09-0054, K24DK065018 |
| Study First Received: | May 20, 2009 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Colorado, Denver:
|
Obesity Weight loss Meal replacements Health services research |
Additional relevant MeSH terms:
|
Obesity Weight Loss Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms Body Weight Changes |
ClinicalTrials.gov processed this record on May 21, 2013